35 spine, orthopedic devices receive FD A 510(k) clearance in September 2016

Written by Laura Dyrda | October 12, 2016 | Print  |

The Food and Drug Administration granted 35 spine- and orthopedic-related device clearances in September.

1. Additive Orthopaedics Bone Wedge System from Additive Orthopaedics.

 

2. coflex-IF from Paradigm Spine.

 

3. RTS Flexible 1 MPJ Implant w/Grommets from In2BonesUSA.

 

4. Prow Fusion-L from NLT Spine.

 

5. Pro-Link Standalone Cervical Spacer System from Life Spine.

 

6. Active-X Total Knee System from Signature Orthopaedics.

 

7. DePuy Synthes TFNA Augmentation System from Synthes (USA) Products.

 

8. PASS XS Spinal System from Medicrea International.

 

9. LigaPASS from Medicrea International.

 

10. Battalion Universal Spacer System from Alphatec Spine.

 

11. NuVasive Reline System from NuVasive.

 

12. SeaSpine Shoreline ACS – Anterior Cervical Standalone System from SeaSpine Orthopedics.

 

13. Karl Storz Flexible Video-Neuro-Endoscope System from Karl Storz Endoscopy-America.

 

14. Pillar SA PTC from Orthofix.

 

15. Spinal fixation system from Canwell Medical.

 

16. StageOne Select Cement Spacer Molds for Temporary Hip Replacement from Biomet.

 

17. Avenue T TLIF Cage from LDR Spine USA.

 

18. ELSA Spacers from Globus Medical.

 

19. NuVasive CoRoent Small Interlock System from NuVasive.

 

20. Xenco Medical Posterior Cervical System from Xenco Medical.

 

21. Nanovis Intervertebral Body Fusion System and Forticore from Nanovis.

 

22. Tangis Anterior Cervical Plate from Nvision Biomedical Technologies.

 

23. SeaSpine NewPort Spinal System from SeaSpine Orthopedics.

 

24. Arthrex Synergy RF System from Arthrex.

 

25. Quartex Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments from Globus Medical.

 

26. InterForm Cervical Interbody Cage System from Next OrthoSurgical.

 

27. Arix Hand System from Jeil Medical.

 

28. MAGEC Spinal Bracing and Distraction System from NuVasive Specialized Orthopedics.

 

29. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.

 

30. Juliet LL Lateral Lumbar Cage from Spineart.

 

31. EXPRT Revision Knee Femoral Augment, EXPRT Revision Knee Stem Extension from Encore Medical.

 

32. dS FootAnkle I6CH 1.5T Coil from InVivo.

 

33. GENflex2 Total Knee System from StelKast.

 

34. Cascadia Interbody System from K2M.

 

35. OrthoPediatrics Locking Proximal Femur System from Cortical Screws from Orthopediatrics.

 

More articles on FDA clearance:
29 spine, orthopedic devices receive FDA 510(k) clearance in August
42 spine, orthopedic devices receive FDA 510(k) clearance in July
31 spine and orthopedic devices receive FDA clearance in June

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